Cleared Traditional

K960747 - NATURE'S CRADLE MODEL C1500 (FDA 510(k) Clearance)

May 1996
Decision
89d
Days
Class 2
Risk

K960747 is an FDA 510(k) clearance for the NATURE'S CRADLE MODEL C1500. This device is classified as a Bed, Pediatric Open Hospital (Class II - Special Controls, product code FMS).

Submitted by Infant Advantage, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 22, 1996, 89 days after receiving the submission on February 23, 1996.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5140.

Submission Details

510(k) Number K960747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1996
Decision Date May 22, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMS — Bed, Pediatric Open Hospital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5140